Quality Engineer, Medical Devices — Drive New Product Launch

Venture Hire Group LLC; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Venture Hire Group LLC in San Diego is seeking a Quality Engineer to shape the next generation of medical device technology. You will engage early in development, ask critical questions, and help teams turn promising designs into launch-ready products.

You will focus on new product development, with involvement in improving existing devices and resolving issues. A strong mechanical foundation and collaboration across disciplines are essential to thrive.

Qualifications

• Bachelor’s degree in Mechanical Engineering or a related field.
• Medical device quality engineering or design assurance experience with development and launch of new products.
• Understanding of design controls, verification & validation, and risk management tools such as DFMEA and PFMEA.
• Familiarity with mechanical components, assemblies, manufacturing methods, and product reliability.
• Experience working within an ISO 13485 quality system and applying FDA requirements.

Responsibilities

• Identify quality considerations early with product development engineers.
• Review requirements, documentation, and test plans to confirm evidence.
• Assess risks and establish safeguards to prevent failures.
• Link product requirements to testing and risk controls to demonstrate device performance.
• Collaborate with manufacturing and supplier teams to prepare designs for production.
• Investigate performance issues, determine root causes, and implement lasting improvements.

Skills

Design controls

Verification & Validation

Risk management

DFMEA

PFMEA

ISO 13485

FDA regulatory knowledge

Education

Bachelor's degree in Mechanical Engineering

Job description

Venture Hire Group LLC in San Diego is seeking a Quality Engineer to shape the next generation of medical device technology. You will engage early in development, ask critical questions, and help teams turn promising designs into launch-ready products.

You will focus on new product development, with involvement in improving existing devices and resolving issues. A strong mechanical foundation and collaboration across disciplines are essential to thrive.